Clinical Start-up Unit (CSU)
The conduct for clinical cancer trials has become more complex, which impacts drug development timelines. In response to the need to expedite trial execution, TRIO has set up a Clinical Start-Up Unit (CSU). This unit continuously develops best practices and gathers intelligence on sites and countries including metrics (time to submission, approval time, time to activation, enrolment). Throughout the years, the CSU has selected a preferred network of about 300 sites spanning over 30 countries.
For each trial, this unit is responsible for identifying the most suitable sites within the TRIO investigator network. This enables rapid accrual while also meeting the constraints of the project.
The unit is also responsible for expediting site activation. For each site, a single team member is accountable for performing country/site level tasks leading to activation (including but not limited to adjustments to the Informed Consent Form (ICF), contract negotiation, ethics submission support and coordination of the site initiation visit (SIV).
The CSU team is based out of our Edmonton and Paris offices to ensure close and transparent communication with our global network of sites. A global point of contact is responsible for the ongoing and transparent reporting of CSU activity to the study team. The creation of the CSU has allowed us to continuously reduce the timeframe for median site activation.